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FDA Won't Change Breast Implant Ban, for One Brand



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Dr. Kim Mulvihill reportingBy a very narrow vote, FDA advisors have decided against putting ONE brand of silicone breast implants back on the market.

The question revolved around whether their product leaks, and what happens if it does.

After two grueling days of testimony - advisors to the FDA gave a thumbs down to silicone breast implants.

Brent Blumenstein, Ph.D./ FDA Advisor on Breast Implants: "I believe there is not adquate data to allow us to assess safety of this device."

Amy Newberger, M.D: "I don't feel secure about the safety. I don't think at this time patients can give informed consent."

Not everyone agreed. Four of the nine experts, including UCSF's Dr. Cheryl Ewing, wanted to see these implants available to

Cheryl Ewing, MD: "As a clinician, I'm somewhat disappointed."

The issue is how often these devices fall apart in women's bodies and what happens when they do.

Everyone at the hearing agreed: they can rupture. And they won't last forever.

Patricia Walker, M.D./ Inamed Company: "What the actual lifetime is, we can't give an actual lifetime because it does depend on individual implant and an individual patient."

The implants under question were studied for just three years - and depending upon the model, roughly one to twenty percent of them ruptured within three years, and that meant additional surgery.

The news was a disappointment to some women - - and surgeons who want to use them.

Dr. Joseph Disa/ Memorial Sloan Kettering: "Their track record is sound, superior to saline. Patients deserve a choice. There is no evidence safety is compromised with these devices."

Cynthia Russell/ Breast Cancer Survivor: "This decision is a personal one. Everyone should be allowed to make their own choice."

Today, the second California company that makes implants will present its case, and there will be a second vote to see if history repeats itself.

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